[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Notices]
[Pages 39274-39275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14212]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee. The general
function of the committee is to provide advice and recommendations to
the Agency on FDA's regulatory issues. The meeting will be open to the
public.
DATES: The meeting will be held on June 28, 2016, from 8 a.m. to 3:15
p.m., and June 29, 2016, from 8 a.m. to 4:15 p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On June 28, 2016, information will be presented to gauge
investigator interest in exploring potential pediatric development
plans for four products in various stages of development for adult
cancer indications. The subcommittee will consider and discuss issues
concerning diseases to be studied, patient populations to be included,
and possible study designs in the development of these products for
pediatric use. The discussion will also provide information to the
Agency pertinent to the formulation of written requests for pediatric
studies, if appropriate. The products under consideration are: (1)
VENETOCLAX, application sponsored by AbbVie, Inc.; (2) TAZEMETOSTAT,
application sponsored by Epizyme, Inc.; and (3) ATEZOLIZUMAB,
application sponsored by Roche/Genentech.
On June 29, 2016, during the morning session, information will be
presented to gauge investigator interest in exploring potential
pediatric development plans for two products in various stages of
development for adult cancer indications. The subcommittee will
consider and discuss issues concerning diseases to be studied, patient
populations to be included, and possible study designs in the
development of these products for pediatric use. The discussion will
also provide information to the Agency pertinent to the formulation of
written requests for pediatric studies, if appropriate. The products
under consideration are: (1) LOXO-101, application sponsored by Loxo
Oncology, Inc.; and (2) ENTRECTINIB, application sponsored by Ignyta,
Inc.
During the afternoon session, information will be presented on the
current unmet clinical need in the nearly uniformly fatal brain tumor,
diffuse intrinsic pontine glioma (DIPG), which occurs predominantly in
the pediatric age group. The diagnosis of DIPG is typically based on
characteristic radiographic and clinical features in lieu of brain
biopsy, and histological confirmation. Recent data has demonstrated
that the biology and pathophysiology of these tumors differ. There are
no approved drugs for this disease. Clinical investigators seek to
exploit precision medicine approaches to DIPG and use potentially
predictive information from the genomic signature of tumors at either
diagnosis or relapse. This information can be used to select specific
molecularly targeted drugs based on the genetic aberrations of an
individual patient's tumor. The Agency will seek the input of the
subcommittee, including an assessment of benefit/risk given the
potential for an adverse event associated with a surgical intervention
in the brainstem.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views,
[[Page 39275]]
orally or in writing, on issues pending before the subcommittee.
Written submissions may be made to the contact person on or before June
21, 2016. Oral presentations from the public will be scheduled between
approximately 8:50 a.m. and 9:10 a.m., 11 a.m. and 11:20 a.m., 1:55
p.m. and 2:15 p.m., and 3:50 p.m. and 4:05 p.m. on June 28, 2016, and
between approximately 8:50 a.m. and 9:10 a.m., 10:55 a.m. and 11:15
a.m., and 3 p.m. and 3:20 p.m. on June 29, 2016. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before June 16, 2016. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by June 17, 2016.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Lauren D. Tesh at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-14212 Filed 6-15-16; 8:45 am]
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